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ACTIVE NOT RECRUITING
NCT04798833
NA

Newborn Care Kit to Save Lives in GB, Pakistan

Sponsor: The Hospital for Sick Children

View on ClinicalTrials.gov

Summary

Neonatal deaths account for almost half of all deaths in children under 5 years of age. Pakistan has the world's highest neonatal mortality rate (NMR), and many of these deaths are preventable. In this study, the investigators propose the use of an evidence-based, integrated newborn care kit (iNCK) to promote safer delivery, provide early identification of danger signs, improve newborn health, and reduce NMR. The investigators hypothesize that use of the iNCK will result in at least a 25% reduction in NMR among participants who receive the iNCK compared with participants who do not receive the iNCK.

Official title: An Integrated Newborn Care Kit to Save Newborn Lives and Improve Health Outcomes in Gilgit-Baltistan, Pakistan

Key Details

Gender

FEMALE

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

27448

Start Date

2021-06-01

Completion Date

2025-12

Last Updated

2025-06-06

Healthy Volunteers

No

Interventions

DEVICE

Integrated Newborn Care Kit (iNCK)

Contents of the integrated newborn care kit: * Clean birth kit: sterile blade, clean plastic sheet, plastic gloves, hand soap, cord ties/clamp, maternity pad to absorb post-natal bleeding, 10 cotton balls for applying Chlorhexidine (CHX) to the umbilical stump. * 3x200 µg dissolvable tablets of misoprostol to be ingested prophylactically following delivery of the baby and before delivery of the placenta to prevent post-partum hemorrhage * 4% CHX solution (15 mL) * Sunflower oil emollient (50 mL) * Temperature monitoring strip or sticker * Fleece blanket for the newborn * Click to heat warmer * Pictorial guide that illustrates how and when to use each kit component * Handheld electronic scale with suspended cloth sling (the scale will not be included with the kit but rather one will be issued to each Lady Health Worker in the experimental arm) Other Names: Neonatal Care Kit

Locations (2)

Aga Khan Health Services, Pakistan

Islamabad, Pakistan

Aga Khan University

Karachi, Pakistan